Quality Key Performance Indicators (KPIs) are measurable values that assess how effectively an organization is achieving its quality objectives. Quality KPIs are essential in a Quality Management System (QMS) to support sustainable compliance, continuous improvement, and data-driven decision-making.
The quality KPIs are categorized into the following types.
- 1. Product Quality KPIs: Measure product quality and compliance with specifications.
- 2. Process Quality KPIs: Track process performance, consistency, and efficiency.
- 3. Compliance and Regulatory KPIs: Monitor adherence to legal requirements and standards.
- 4. Risk and Safety KPIs: Evaluate effectiveness in managing operational and product risks.
- 5. Supplier Quality KPIs: Assess supplier reliability and raw material quality.
- 6. Customer Satisfaction KPIs: Gauge customer satisfaction and loyalty.
- 7. Continuous Improvement KPIs: Measure the implementation timeliness and impact of improvement initiatives.
QMS software can support KPI management, providing capabilities such as centralized data collection and reporting. QMS software ensures access to reliable data sources, visibility across departments, and audit readiness.
SimplerQMS is a QMS software tailored for life science companies. SimplerQMS supports compliance with major life science requirements while streamlining KPI monitoring through centralized data access across all QMS processes and integrated reporting capabilities.
1. Product Quality KPIs
Product quality KPIs assess how well products meet specifications and regulatory requirements.
The most common product quality KPIs are the following.
- Batch Release Rate (Lot Acceptance Rate): Measures the percentage of batches released compared to the total number of batches processed within a specific timeframe.
- Product Recall Rate: Tracks the percentage of products withdrawn from the market due to quality, compliance, safety, or efficacy issues.
- Out-of-Specification (OOS) Rate: Represents the percentage of test results that fall outside approved specification limits.
- Critical Quality Attribute (CQA) Process Capability: Monitors how consistently products meet predefined critical attributes.
- Confirmed Complaints Rate: Measures the proportion of customer complaints that are confirmed after investigation, reflecting product or service quality defects.
Other product quality KPIs include non-compliance rate per product and stability failure rate. The non-compliance rate per product shows non-compliance trends for each product. Stability failure rate measures a product’s ability to meet specifications throughout its shelf life.
Batch Release Rate
Batch release rate or Lot Acceptance Rate (LAR) is a quality KPI that measures the percentage of processed batches approved and released to the market.
The lot acceptance rate calculation is based on the total number of processed batches within a given period and the number of batches released to the market after meeting their predefined specifications.
The following formula is used to calculate the batch release rate.
(Number of Batches Released ÷ Total Batches Produced) × 100 = Batch Release Rate (%)
A high batch release rate indicates that most batches meet specifications and pass quality control testing. A lower rate highlights quality issues in the final product and the inability to meet specifications.
The batch release rate represents the consistency and reliability of product quality delivered to customers.
Product Recall Rate
Product recall rate tracks the proportion of released batches that must be withdrawn from the market due to safety, efficacy, quality, or compliance failures. The product recall rate measures the extent to which significant quality issues escape detection before batch release or arise during stability studies.
Key inputs for calculating the product recall rate include the total number of batches released to the market in a given period and the number of those batches recalled.
The product recall rate is calculated using the formula below.
(Number of Batches Recalled ÷ Total Batches Released) × 100 = Product Recall Rate (%)
A low product recall rate indicates that any product quality defects are detected early, before the batch reaches the market. A higher rate indicates gaps in product quality assurance, increasing regulatory and reputational risks.
The product recall rate is an important KPI because recalls directly impact patient safety and company credibility. It serves as a strong indicator of both product quality and the effectiveness of the quality management system.
Out Of Specifications Rate
Out of Specification (OOS) Rate indicates the percentage of batches or lots that yield test or inspection results outside approved specification limits or acceptance criteria.
Key inputs include the total number of batches, or lots tested by QC, and the number of batches where OOS results were identified. OOS results may arise during finished product testing for release or stability, in-process controls (IPC) for intermediates or components, or raw material analysis.
The calculation formula for the OOS rate is given below.
(Batches with OOS Results ÷ Total Number of Batches Tested) × 100 = OOS Rate (%)
A lower OOS rate reflects more consistent product quality and process control. The OOS rate indicator complements the batch release rate, since OOS results often lead to batch rejection.
Tracking the OOS rate helps identify variability in analytical or manufacturing processes and highlights instances where products fail to meet specifications.
CQA Process Capability
Critical Quality Attribute (CQA) process capability measures how well a manufacturing process consistently produces products that meet predefined specifications. It evaluates the product’s performance against specification limits using capability indices, such as process capability (Cp) and process capability index (Cpk), for short-term variation, and process performance (Pp) and process performance index (Ppk) for long-term performance. Cp and Pp measure overall spread relative to the specification limits, while Cpk and Ppk reflect both spread and centering of results within those limits.
The CQA process capability is calculated using specification limits for each critical quality attribute, the mean value of test results, and the standard deviation of measured data.
The calculation formula for the CQA process capability is presented below.
(USL – LSL) ÷ (6 × Standard Deviation) = Cp
min[(USL – Mean), (Mean – LSL)] ÷ (3 × Standard Deviation) = Cpk
USL is the upper specification limit, and LSL is the lower specification limit.
Pp and Ppk use similar formulas but use overall standard deviation instead of within-subgroup deviation.
In practice, higher capability indices indicate a process that consistently produces products within specification limits. Lower values suggest a greater risk of OOS results and batch rejections.
CQA process capability serves as a critical leading indicator of product quality. The CQA process capability enables organizations to anticipate risks before defects occur, ensuring ongoing compliance with product specifications.
Confirmed Complaints Rate
The confirmed complaints rate measures the proportion of customer-reported issues that are confirmed as actual product or service defects.
The components of the confirmed complaints rate include the total number of confirmed complaints received per product during a specified timeframe (e.g., quarterly, annually) and the number of batches or units distributed in the same time period.
The formula used to calculate the confirmed complaints rate is shown below.
(Number of Confirmed Complaints ÷ Units or Batches Distributed) × Multiplier = Confirmed Complaints Rate
The multiplier is a scaling factor (e.g., per 1,000 or 10,000 units) used to normalize the rate based on sales volume.
A high confirmed complaint rate may point to product or process issues that require corrective action. A lower rate could indicate effective controls over processes. On the other hand, a low rate may reveal ineffective investigation practices that lead to misclassification of complaints as unconfirmed.
The confirmed complaints rate matters because confirmed complaints directly reflect underperforming products or services. Monitoring confirmed complaints per product helps identify areas for improvement, protect customer trust, and ensure effective complaint management.
2. Process Quality KPIs
Process quality indicators focus on how well processes function to deliver compliant products. Process quality KPIs measure the effectiveness and consistency of activities that support manufacturing, testing, distribution, and quality assurance.
Process quality KPIs typically include the following.
- Right First Time (RFT): Tracks the percentage of processes completed without errors or rework, showing the degree of process standardization and execution accuracy.
- Non-Conformance Rate: Measures the frequency of quality failures relative to the total number of executed processes, highlighting areas of weakness.
- Cycle Time: Represents the total time taken to complete a defined process from initiation until completion, indicating process efficiency.
- Change Control Implementation Success: Evaluates the percentage of change controls implemented on time and according to plan, without introducing new issues.
Other process quality KPIs include the invalidated OOS rate and aseptic process simulation (Media Fill) pass rate. The invalidated OOS rate measures the reliability of laboratory testing and the OOS investigation process. The aseptic process simulation pass rate assesses the effectiveness of controls in place for sterility assurance in aseptic manufacturing environments.
Right First Time
Right First Time (RFT) measures the percentage of processes completed correctly without the need for corrections, repeats, or rework. RFT reflects how often processes achieve predefined specifications on the first attempt.
Usually, the key inputs for RFT are the total number of executed batches or processes and the number of those completed without error or rework.
The calculation formula for the right first time is given below.
((Total Processes- Defective Processes) ÷ Total Processes) × 100 = (%) RFT
High RFT values demonstrate strong process control and minimal delays caused by non-conformances or reprocessing.
RFT is an important indicator because it reflects process standardization. A strong RFT performance ensures fewer operational disruptions, faster product release, and greater confidence in product quality.
Non-Conformance Rate
Non-conformance rate reflects the proportion of products or processes that do not meet predefined specifications, criteria, or parameters. Non-conformance rate measures the extent of failures detected during execution and serves as a complementary KPI to right first time, since reducing non-conformances helps improve RFT.
The inputs for non-conformance rate calculation are the total number of products or processes assessed and the number of non-conformances recorded.
The calculation formula for the non-conformance rate is the following.
(Number of Non-conformances ÷ Number of Assessed Products or Processes) × 100 = Non-conformance Rate (%)
Tracking non-conformance rate helps identify recurring issues in workflows. A high rate of non-conformances in specific areas indicates systemic weaknesses, while a lower rate reflects strong process control and effective quality systems.
The non-conformance rate can provide insights into process reliability and risks that compromise quality outcomes. Monitoring non-conformances allows organizations to identify patterns, strengthen control over processes, and reduce the likelihood of repeated quality failures.
Cycle Time
Cycle Time represents the total duration required to complete a process from its initiation until its endpoint. Cycle time applies to a range of operations, such as manufacturing cycle time, analytical testing cycle time, and batch release cycle time.
Inputs include the recorded start time of the process and the recorded completion time.
The cycle time calculation formula is the following.
Process End Time – Process Start Time = Cycle Time
Generally, shorter cycle times indicate streamlined processes that deliver results more quickly, while longer times reveal bottlenecks or inefficiencies.
Cycle time reflects the speed, efficiency, and responsiveness of critical workflows. Reducing cycle times can lead to faster product release, improved supply chain reliability, and enhanced competitiveness.
Change Control Implementation Success Rate
Change control implementation success rate measures the percentage of changes executed without creating unintended risks or post-implementation issues.
The key inputs used to calculate the change control implementation success rate include the total number of changes implemented within a specific timeframe and the subgroup of those completed without issues after implementation.
The calculation formula is given below.
(Number of Changes with Zero Issues ÷ Total Implemented Changes) × 100 = Change Control Implementation Success (%)
In practice, higher values of change control implementation success rate indicate that changes are well-assessed and properly executed. Lower results point to weaknesses in impact assessments or change implementation planning that increase compliance and operational risks.
Monitoring the change control implementation success rate ensures that modifications to processes, systems, or documentation do not introduce unintended consequences or risks.
3. Compliance and Regulatory KPIs
Compliance and regulatory KPIs measure how effectively an organization adheres to legal and regulatory requirements. Compliance and regulatory key performance indicators focus on readiness for inspections, timely resolution of compliance gaps, and adherence to regulatory obligations.
Common compliance and regulatory KPIs are listed below.
- Significant Audit Findings Rate: Tracks the proportion of major or critical findings identified during audits, revealing the extent of compliance gaps.
- CAPA Closure Timeliness: Measures the percentage of corrective and preventive actions closed within defined deadlines, reflecting responsiveness to compliance issues.
- Training Compliance Rate: Represents the number of employees who complete mandatory training on time, demonstrating staff qualification status.
- Inspection Readiness Score: Assesses preparedness for regulatory inspections based on internal evaluations, audits, and availability of required documentation.
- Regulatory Commitments On-Time Completion: Tracks how many regulatory submissions, responses, or commitments are delivered by agreed deadlines, indicating reliability in external compliance obligations.
Other compliance and regulatory KPIs include internal audit schedule adherence and inspection finding closure time. Internal audit schedule adherence measures how consistently internal audits are conducted as planned. Inspection finding closure time monitors how quickly inspection findings are remediated to restore compliance.
Significant Audit Findings Rate
Significant audit findings rate counts the proportion of major and critical findings identified during audits. The significant audit findings rate measures the frequency of severe compliance gaps that directly impact product or service quality, or even patient safety.
Key inputs are the total number of audit findings and the number of those classified as major or critical.
The significant audit findings rate is calculated based on the following formula.
((Major + Critical Findings) ÷ Total Audit Findings) × 100 = Significant Audit Findings Rate (%)
A low rate of significant audit findings shows that most of the observations during audits are minor, indicating an effective quality management system. A higher rate points to more frequent, severe compliance gaps.
Major and critical audit findings can jeopardize product safety, product or service quality, and organizational credibility. Tracking the significant audit findings rate helps ensure that compliance gaps are monitored and that corrective actions are prioritized.
The primary goal for the company is to receive a very low number, or even zero, significant audit findings. In the event that this goal is achieved, the audit findings rate may be used as a KPI. Audit findings rate tracks the total number of quality or compliance issues identified during audits relative to the number of audits conducted.
CAPA Closure Timeliness
CAPA closure timeliness measures the percentage of corrective and preventive actions that are completed within defined due dates. CAPA closure timeliness reflects the organization’s ability to respond to quality or compliance issues in a controlled and timely manner.
Inputs for calculating CAPA closure timeliness include the total number of CAPAs planned for completion within a specific timeframe and the number of those closed within their target due dates.
The calculation formula for CAPA closure timeliness is given below.
(CAPAs Closed on Time ÷ Total CAPAs Due for Closure) × 100 = CAPA Closure Timeliness (%)
Higher values indicate strong follow-up discipline and effective allocation of resources. Lower values suggest delays in addressing compliance or quality risks, which may lead to recurring issues or even regulatory actions.
Timely CAPA closure demonstrates control over non-conformances and audit findings, reduces the likelihood of repeated quality defects, and provides assurance to auditors that the organization maintains an effective CAPA management system.
Training Compliance Rate
The training compliance rate is an indicator of the qualification status of personnel. The training compliance rate measures the percentage of assigned training sessions that are completed within the required timelines.
Key components of the training compliance rate are the total number of required training assignments and the number of those completed on time.
The formula used to calculate the training compliance rate is shown below.
(Completed Trainings on Time ÷ Total Required Trainings) × 100 = Training Compliance Rate (%)
Higher training compliance rates confirm that staff are properly trained to perform assigned tasks in line with current procedures and regulatory requirements. Lower rates may reveal compliance gaps and risks related to unqualified personnel handling critical operations.
The training compliance rate is important because companies are expected to provide evidence that their employees are trained and competent to perform their tasks. A strong training compliance rate not only helps maintain inspection readiness but also ensures consistent execution of processes.
Inspection Readiness Score
Inspection readiness score reflects the degree to which an organization is prepared for regulatory inspections at any point in time.
Inputs used for the calculation of inspection readiness score may include the findings of recent external, internal, and mock audits and their significance, documentation reviews, personnel interview results, and management review outcomes.
Calculation is typically based on a weighted scoring method that assigns relative importance to each input selected by the organization.
A higher score signals strong compliance with internal procedures and regulatory requirements, complete and traceable documentation, and properly qualified staff. Maintaining high inspection readiness scores reduces the risk of critical findings. A lower score indicates weaknesses that should be addressed to ensure successful outcomes during the next inspections.
The inspection readiness score matters because regulatory inspections directly impact market access and company reputation.
Regulatory Commitments On-Time Completion
Regulatory commitments on-time completion measures the percentage of regulatory obligations delivered within the agreed deadlines. Regulatory commitments on-time completion evaluates how reliably an organization meets external commitments to authorities, such as responses to inspection findings, submission of periodic safety reports, or technical dossier updates.
Inputs include the total number of regulatory commitments due and the number of those completed by the specified deadline.
The calculation formula for regulatory commitments on-time completion is given below.
(Commitments Completed on Time ÷ Total Commitments Due) × 100 = Regulatory Commitments On-Time Completion (%)
Higher percentages of regulatory commitments completed on time indicate that the organization consistently meets deadlines and maintains strong regulatory relationships.
The percentage of regulatory commitments completed on time is a key indicator because missed commitments can harm credibility with regulatory agencies, delay authorization approvals, and create legal consequences. Strong performance shows discipline in compliance management and supports long-term regulatory trust.
4. Risk and Safety KPIs
Risk and safety KPIs evaluate how well an organization identifies, manages, and reduces risks that impact product or service quality, regulatory compliance, and patient safety. Risk and safety indicators provide insight into the robustness of the risk management system and its integration within the QMS.
Below are the most frequently applied risk and safety KPIs.
- Number of Overdue Risk Assessments: Tracks the count of risk assessments not completed within scheduled timelines, showing potential gaps in proactive risk control.
- Recurring Non-Conformance Rate: Measures how often the same or similar non-conformances reappear, highlighting weaknesses in root cause analysis or CAPA effectiveness.
- Number of Serious Adverse Events: Represents the frequency of serious events linked to product use, directly reflecting product safety and patient impact.
Other risk and safety KPIs include the overdue high-risk CAPAs rate and error-catch rate. The overdue high-risk CAPAs rate is a subset of CAPA timeliness metrics that emphasizes the closure of risk-critical actions. Error-catch rate tracks the number of potential failures detected and corrected before reaching the next process step, serving as a leading indicator to identify risk areas.
Number of Overdue Risk Assessments
The number of overdue risk assessments counts how many planned risk assessments were not completed by their scheduled due date. The number of overdue risk assessments is an indication of delays in evaluating and managing risks that may affect product quality, patient safety, or regulatory compliance.
The inputs used for calculating the number of overdue risk assessments are the total number of risk assessments scheduled during a specific timeframe and the number that remain incomplete past their assigned deadline.
In practice, higher counts indicate resource constraints, weak planning, or a lack of prioritization in risk management. Lower numbers show that risks are being reviewed on schedule, maintaining proactive oversight.
Counting the number of overdue risk assessments is critical because overdue assessments leave potential risk unaddressed and increase the chance of quality or operational failures. Timely completion of risk assessments ensures risks are continuously monitored and managed before they escalate.
Recurring Non-Conformance Rate
Recurring non-conformance rate measures how frequently the same or similar non-conformances recur in a product, process, or system after corrective actions have been implemented.
The key components of the recurring non-conformance rate include the total number of non-conformances recorded and the number identified as repeat issues within a defined timeframe.
The calculation formula for the non-conformance rate is the following.
(Number of Recurring Non-Conformances ÷ Total Non-Conformances) × 100 = Recurring Non-Conformance Rate (%)
The interpretation of this KPI focuses on whether quality issues are being permanently resolved. A lower rate indicates that corrective actions and preventive measures are effective, while a higher rate reveals gaps in root cause analysis or CAPA implementation and effectiveness.
CAPA effectiveness can be used as an alternative or a complementary KPI to the recurring non-conformance rate. CAPA effectiveness measures the percentage of CAPAs that have resolved the root cause without recurrence, demonstrating the ability to correct and prevent issues effectively.
Number of Serious Adverse Events
The number of serious adverse events represents the count of adverse events linked to a product or device that result in serious outcomes such as hospitalization, disability, or death.
Inputs include the total number of adverse events reported and the subset classified as serious according to regulatory definitions.
Higher numbers highlight potential severe product or device risks, requiring immediate investigation.
The number of serious adverse events reported for a drug product or a medical device serves as a safety performance indicator once the product is used in real-world conditions. Serious adverse events may reveal critical quality issues, such as cross-contamination or manufacturing defects.
5. Supplier Quality KPIs
Supplier quality KPIs help evaluate supplier compliance status, consistency, and overall contribution to final product quality. Supplier quality KPIs measure how effectively suppliers deliver materials and services that meet defined quality and compliance requirements.
The most common supplier quality KPIs are listed below.
- Lot Acceptance Rate: Tracks the percentage of supplier lots that meet specifications and are released upon QC testing.
- Supplier-Caused Non-Conformance Rate: Measures the proportion of non-conformances directly linked to supplier materials or services.
- Number of Supplier Audit Findings per Audit: Represents the number of major or critical findings detected during supplier audits, reflecting compliance and the maturity of the supplier’s QMS.
Other supplier quality KPIs include the supplier scorecard and CAPA response and closure time. Supplier scorecards consolidate multiple metrics to provide an overall supplier performance rating. CAPA response and closure time tracks how quickly suppliers address and resolve quality issues raised through audits or non-conformances.
Lot Acceptance Rate
The lot acceptance rate shows the percentage of supplier lots that meet requirements and are released for further processing.
Lot acceptance rate is calculated using the total number of lots received from a specific supplier and the number of those accepted after inspection and QC testing.
The formula used for calculation is the following.
(Accepted Lots ÷ Total Lots Received) × 100= Lot Acceptance Rate (%)
The lot acceptance rate measures the consistency of supplier quality in delivered materials. Higher rates indicate that suppliers provide materials conforming to specifications, reducing delays.
Supplier lot acceptance rate impacts final product quality, regulatory compliance, and customer trust. A strong acceptance rate supports supply chain reliability and helps reduce operational disruptions.
Supplier-Caused Non-Conformance Rate
Supplier-caused non-conformance rate measures the proportion of quality defects in products or processes that are directly traced back to supplier materials or services.
The key components for calculating the supplier-caused non-conformance rate are the total number of non-conformances recorded and the subset attributed to a specific supplier.
The calculation formula used for the supplier-caused non-conformances rate is given below.
(Supplier-Related Non-Conformances ÷ Total Non-Conformances) × 100 = Supplier-Caused Non-Conformance Rate (%)
It is recommended to calculate this metric separately for each supplier to gain better insight into individual suppliers’ performance.
Low percentages of supplier-caused non-conformances generally indicate stronger supplier reliability and improved quality of raw materials or services. Supplier responsiveness further shapes how effectively these issues are managed.
Unresolved or repeated supplier-related non-conformances can disrupt operations, raise compliance risks, and increase costs. Monitoring supplier-caused non-conformance rate supports supplier performance evaluation and strengthens overall product quality.
Number of Supplier Audit Findings per Audit
The number of supplier audit findings per audit counts the number of findings identified during each supplier audit. Particular attention should be given to significant (major or critical) findings, which reveal serious compliance gaps and QMS inefficiencies. The number of supplier audit findings is especially important for high-risk suppliers, such as active pharmaceutical ingredient (API) manufacturers, where oversight is most critical.
Inputs include the total number of audit findings, ideally categorized by severity, per audit, per supplier.
A lower number of audit findings shows that the supplier’s QMS is effective, and their processes are aligned with regulatory and contractual requirements. A high number of findings or significant audit findings may signal increased risks and the need for close monitoring or corrective actions.
A high number of findings or significant audit findings at the supplier level can affect product quality, patient safety, and compliance. Monitoring the supplier audit findings rate ensures that high-risk suppliers are continuously monitored.
6. Customer Satisfaction KPIs
Customer satisfaction KPIs are indicators of how well an organization meets customer expectations regarding product or service quality and contractual obligations.
The main customer satisfaction KPIs are the following.
- Complaint Resolution Time: Tracks the average time taken to resolve customer complaints, showing the company’s responsiveness.
- Customer Complaints Rate: Measures the number of customer complaints per volume of product released or shipped.
- QTA Compliance Rate: Counts the percentage of Quality Technical Agreements (QTAs) maintained in compliance without issues, demonstrating reliability in meeting contractual quality expectations.
Other customer satisfaction KPIs include the customer effort score and the order backlog. The customer effort score assesses how easy it is for customers to interact with the company. The order backlog measures unfulfilled customer orders that may impact satisfaction levels.
Complaint Resolution Time
Complaint resolution time measures the average duration it takes to resolve a customer complaint from the time it is received until it is formally closed.
The key inputs needed to calculate the average complaint resolution time are the date that a complaint is received and the date the complaint is closed after quality investigation completion.
The calculation formula for complaint resolution time is the following.
Sum of Individual Complaint Completion Durations ÷ Total Number of Complaints = Complaint Resolution Time
In general, shorter resolution times demonstrate responsiveness and efficient complaint management, while longer times may signal inefficiencies or resource constraints in the investigation process.
Complaint resolution time reflects how quickly an organization addresses customer-reported issues. Complaint resolution time is an important indicator since unresolved or delayed complaints can lead to customer dissatisfaction and damage to the company’s reputation.
Customer Complaints Rate
The customer complaints rate calculates the number of customer complaints received relative to the total volume of products released or shipped. The customer complaints rate reflects not only customer satisfaction, but also product performance.
The components of the customer complaints rate are the total number of customer complaints received for a product and the total number of product units or batches released or shipped within a defined period.
The formula used to calculate the customer complaints rate is shown below.
(Number of Complaints ÷ Total Units or Batches Released) × 100 = Customer Complaints Rate
A low complaint rate indicates a product that consistently meets customer expectations and quality requirements, while a high rate highlights potential issues in manufacturing, packaging, analysis, or distribution that require root cause investigation.
The customer complaint rate can be used as a complementary KPI to the confirmed complaints rate. A high customer complaints rate combined with a low confirmed complaints rate may point to an issue with customer training/education.
Customer complaints are direct indicators of product quality and market performance. Tracking the customer complaint rate supports product quality, continuous improvement, and maintenance of customer trust.
QTA Compliance Rate
The QTA compliance rate tracks the percentage of quality technical agreements that are upheld in compliance without issues. The QTA compliance rate measures adherence to contractual quality obligations agreed upon with customers.
Key inputs include the total number of customers’ QTAs in place and the number of those maintained without deviations.
The calculation formula for the QTA compliance rate is given below.
(QTAs Maintained Without Deviations ÷ Active QTAs) × 100 = QTA Compliance Rate (%)
A higher rate of QTA compliance demonstrates strong control over the handling of customer quality agreements. A lower rate indicates potential gaps in contractual obligations fulfillment.
The QTA compliance rate is a particularly important KPI for contract manufacturers. The QTAs define mutual responsibilities for quality. Thus, maintaining them without issues ensures trust and smooth collaboration with customers.
7. Continuous Improvement KPIs
Continuous improvement KPIs measure how effectively an organization identifies, implements, and sustains improvements in processes, quality, and performance. Continuous improvement KPIs are used to assess progress in reducing waste, increasing efficiency, and strengthening compliance.
The typical continuous improvement KPIs are given below.
- KPI Achievement Rate: Tracks the percentage of set targets reached within a defined period, showing the extent to which the company’s performance goals are met.
- Process Improvement Implementation Rate: Measures the proportion of planned improvement initiatives successfully executed, reflecting commitment to continuous improvement.
- Training Effectiveness Score: Evaluates how well training programs improve employee competence and contribute to performance gains.
- Overall Equipment Effectiveness (OEE): Assesses equipment utilization by combining availability, performance, and quality rates to show how effectively production and laboratory equipment and instruments are used.
- Cycle Time for Improvements: Captures the time between identifying an improvement opportunity and successful implementation, indicating responsiveness to change.
- Cost of Poor Quality (CoPQ): Represents the financial impact of defects, rework, complaints, or failures, highlighting areas where improvements yield cost savings.
Other continuous improvement KPIs include management review timeliness and training hours per employee. The management review timeliness tracks if management reviews are conducted on schedule to support improvement actions. Training hours per employee measure investment in the workforce development plans and capability.
KPI Achievement Rate
KPI achievement rate measures the percentage of organizational targets that are successfully met within a defined period, usually within a year.
The calculation of the KPI achievement rate is based on the total number of KPIs set and the number of KPIs achieved.
The calculation formula is given below.
(Achieved KPIs ÷ Total KPIs Set) × 100 = KPI Achievement Rate (%)
High KPI achievement rates demonstrate strong alignment between strategy and execution, while lower rates reveal gaps in performance management.
KPI achievement rate supports accountability, as company-level KPIs should cascade down to departmental KPIs, which in turn link directly to employee KPIs, creating a connected chain of actions.
Tracking the KPI achievement rate ensures that organizational goals are systematically pursued and met. KPI achievement rate can be used to reinforce responsibility at every level and to show how efforts across departments contribute to overall success.
Process Improvement Implementation Rate
Process improvement implementation rate measures the proportion of planned improvement initiatives that are successfully executed.
The inputs for process improvement implementation rate are the total number of planned improvement initiatives and the number of those implemented.
The calculation formula for process improvement implementation rate is the following.
(Implemented Improvements ÷ Planned Improvements) × 100 = Process Improvement Implementation Rate (%)
A high percentage of implemented process improvements indicates that improvement projects lead to actionable results, while a lower rate suggests barriers in execution or follow-through.
A consistent implementation of improvements strengthens processes, reduces inefficiencies, and ensures that identified opportunities deliver measurable value.
Training Effectiveness Score
The training effectiveness score is used to evaluate how well training programs improve employee competence and performance.
Inputs include competency assessments, on-the-job evaluations, supervisor feedback, and observed performance improvements.
The training effectiveness score is typically calculated using a weighted scoring system that combines these inputs into a single performance indicator.
The training effectiveness score measures the real impact of training on workforce capabilities. Higher scores confirm that training enhances employee skills and contributes to quality outcomes, while lower scores indicate the need to revise training content or methods.
The monitoring of the training effectiveness score is significant because effective training ensures employees are competent and able to perform their tasks.
Overall Equipment Effectiveness
Overall Equipment Effectiveness (OEE) measures how well manufacturing or analytical equipment is utilized to deliver quality products.
The inputs for OEE calculation are equipment availability, equipment performance, and product quality.
A simple calculation formula for OOE is the following.
Availability × Performance × Quality = OEE (%)
The explanation of the components of the OEE calculation formula is given below.
(Operating Time ÷ Planned Production Time) × (Actual Output ÷ Ideal Output) × (Good Units ÷ Total Units Produced) = OEE (%)
In practice, higher OEE values show that equipment is running reliably, at the right speed, and producing within specifications. Lower results signal downtime, inefficiencies, or frequent quality issues.
OEE matters because equipment effectiveness directly impacts production capacity, product quality, and operational costs. Monitoring OEE helps prioritize maintenance, optimize processes, and maximize return on equipment investment.
Cycle Time for Improvements
Cycle time for improvement measures the time required to move an improvement initiative from identification to full implementation.
Key inputs include the date an opportunity for improvement is identified and the date the improvement is fully implemented.
The calculation formula for cycle time for improvements is the following.
Implementation Date – Identification Date = Cycle Time for Improvements
Cycle time for improvements reflects how quickly an organization translates improvement opportunities into completed actions. Shorter cycle times indicate that improvements are executed efficiently and deliver value sooner, while longer times suggest delays in decision-making or resource allocation.
Targeting shorter cycle time for improvements is important because improvements may reduce risks, strengthen compliance, and enhance product and process quality.
Cost of Poor Quality
Cost of Poor Quality (CoPQ) measures the financial impact of quality defects that occur during production, analysis, or distribution.
The key components used in calculating the cost of poor quality are the internal failure costs (scrap, rework, retesting) and external failure costs (complaints, recalls, warranty claims).
The formula used to calculate the Cost of Poor Quality is given below.
CoPQ = Internal Failure Costs + External Failure Costs
CoPQ captures the expenses linked to poor quality outcomes, with higher CoPQ values indicating significant losses due to quality issues. Monitoring trends of CoPQ helps identify where preventive measures or process improvements will yield the highest cost savings.
The cost of poor quality is a key indicator because it quantifies the economic burden of poor quality. Reducing CoPQ improves profitability, strengthens competitiveness, and demonstrates that quality is being managed as a measurable business priority.
What Are Quality KPIs (Key Performance Indicators)?
Quality KPIs are measurable values that show how well an organization is achieving its strategic quality objectives.
The primary purpose of quality KPIs is to deliver objective data on performance against predefined quality goals, enabling fact-based decision-making and continuous improvement.
An effective quality KPI is Specific, Measurable, Achievable, Relevant, and Time-bound (SMART). SMART criteria ensure that each indicator produces reliable insights and effectively measures progress towards a defined goal.
Quality KPIs differ from general business KPIs by focusing specifically on quality outcomes such as process consistency, product quality, and compliance. Examples include RFT, OOS Rate, and inspection readiness score. Business KPIs, on the other hand, track broader organizational goals like revenue growth, profitability, or market share.
Quality KPIs can be divided into leading indicators and lagging indicators. Leading indicators, such as CQA process capability, predict potential outcomes and highlight risks before issues occur, enabling proactive intervention. Lagging indicators, such as the confirmed complaint rate, measure results after events have taken place, providing insight into what has already happened. Both perspectives are necessary to manage quality proactively and analyze trends.
The difference between KPIs and KRAs (Key Result Areas) in quality management is scope. KPIs quantify performance through measurable metrics, while KRAs define the critical areas of responsibility where results are expected. For example, “compliance with GMP requirements” is a KRA, while “inspection readiness score” is the KPI used to measure progress in that area.
How Do Quality KPIs Differ Across Life Sciences Industries?
Quality KPIs differ across life sciences industries because each sector operates under distinct regulatory requirements, risk concerns, and operational priorities. Pharmaceutical, medical device companies, or laboratories must tailor their KPIs to align with compliance requirements, product or service quality expectations, and risks related to their product or service.
Within life sciences, quality KPIs are defined and applied to monitor quality system performance and support continuous improvement. Quality KPIs ensure that processes, products, and services consistently meet the company’s quality objectives.
Regulatory and operational factors strongly influence the choice of KPIs. Different frameworks establish varying requirements. Additionally, the type of product or service, and the stage of the product lifecycle, from development to post-market, shape which KPIs are prioritized.
Quality KPIs differ across life sciences because sector-specific needs demand tailored measures. A KPI should be determined based on operational risks, regulatory obligations, and process effectiveness.
What Are the Key Quality KPIs in the Pharmaceutical Industry?
The pharmaceutical industry manufactures, controls, and distributes medicinal products under strict regulatory oversight to ensure patient safety, product quality, and efficacy. The pharmaceutical industry uses quality KPIs to monitor manufacturing consistency, quality control performance, and quality system effectiveness across the product lifecycle.
The key quality KPIs in the pharmaceutical industry are given below.
- Process Capability/Performance Indices (CpK/PpK): Evaluate the capability to meet predefined limits for critical quality attributes, helping assess process robustness and product quality consistency.
- Lot Acceptance Rate (LAR): Measures the percentage of accepted lots, applied to both finished products and incoming raw materials, reflecting manufacturing or supplier quality.
- Right-First-Time (RFT): Tracks the proportion of records, processes, or batches completed without deviation or error, indicating consistency in execution and compliance with GMP expectations.
- Out-of-Specification (OOS) Rate: Represents the frequency of laboratory results outside approved specifications, directly linked to potential batch rejection or product recalls.
- General Quality System Effectiveness Indicators: Include KPIs such as CAPA closure timeliness, change control effectiveness rate, significant audit findings rate, deviation rate, and complaint rate, which together evaluate the maturity of the pharmaceutical quality system.
What Are the Key Quality KPIs in the Medical Device Industry?
The medical device industry designs, manufactures, and markets devices used for diagnosis, treatment, and patient care under highly regulated frameworks such as FDA 21 CFR Part 820 and EU MDR. The medical device industry applies quality KPIs to ensure effective monitoring of product safety and regulatory compliance.
The main quality KPIs used in the medical device industry are the following.
- Non-Conformance Rate: Tracks the proportion of devices or processes that fail to meet specifications, serving as a complementary indicator to RFT.
- Process Quality KPIs: Include KPIs like RFT and process capability indices (CpK/PpK) to evaluate process and product quality consistency.
- Audit Success Rate: Evaluates the percentage of internal, customer, and regulatory audits completed without major or critical findings, indicating system readiness and compliance.
- Post-Market Performance KPIs: Include KPIs such as field action/ recall rate and adverse event rate, which assess product performance and safety post-market release.
- Complaint Rate: Monitors the number of customer complaints relative to total units distributed, indicating device reliability and user satisfaction.
- CAPA Effectiveness: Assesses how well corrective and preventive actions resolve identified issues and prevent recurrence, ensuring continuous compliance and improvement.
- Design Control Adherence: Tracks compliance with design and development requirements, including timely completion and documentation of design history files, to ensure regulatory alignment.
What Are the Key Quality KPIs in Laboratories?
Laboratories provide testing and analytical services that support multiple industries such as pharmaceuticals, biotechnology, and medical devices. They operate under guidelines and standards such as GMP, GLP, ISO 17025, or ISO 15189. Laboratories use quality KPIs to ensure reliability of results, regulatory compliance, and operational efficiency in analytical processes.
The most common quality KPIs used by laboratories are listed below.
- Invalidated Out-of-Specification (OOS) Rate: Measures the proportion of OOS results invalidated after investigation, serving as an indicator of testing reliability.
- First Pass Success Rate: Indicates the percentage of tests completed successfully without the need for retest, rework, or investigation, showing analytical procedure robustness and consistency in execution.
- Calibration Timeliness: Tracks the percentage of instruments calibrated on or before their due date, ensuring accuracy and validity of test results.
- Turnaround Time: Monitors the time taken to complete tests from sample receipt to result delivery, reflecting laboratory responsiveness and customer service.
- Analyst Training Compliance: Assesses whether laboratory personnel complete required training on methods and equipment, ensuring technical competency.
What Is the Difference Between Quality KPIs and Quality Metrics?
The main difference between quality KPIs and quality metrics lies in their purpose and connection to the company’s strategic goals. Quality KPIs focus on how well an organization is achieving its quality objectives, while quality metrics track specific operations.
A quality metric is a quantifiable measurement used to evaluate how well products, services, or processes meet defined targets.
In practice, the two terms overlap because all KPIs are metrics, but not all metrics are KPIs. A quality metric becomes a quality KPI only when it is tied to a strategic quality goal and is used to guide organizational decision-making.
Why Tracking Quality KPIs Is Important?
Tracking quality KPIs is important because, through KPIs, the upper management monitors progress toward strategic quality goals and provides evidence-based data that lead to actionable outcomes.
By measuring performance against predefined quality objectives, organizations can identify gaps, prioritize improvements, and ensure compliance. KPI tracking enables companies to assess and enhance the effectiveness of their quality management system.
What Is the Role of Quality KPIs in Quality Management Systems?
Quality KPIs function within a quality management system as measurable indicators that provide evidence for management review, leading to actionable outcomes.
Within a QMS, KPIs are integrated into routine monitoring and periodic evaluations to assess system effectiveness. Quality KPIs serve as tools for identifying trends and gaps and guiding continuous improvement. Quality KPIs directly assess the effectiveness of the quality management system by linking daily operations to long-term quality goals.
Life science industry requirements emphasize the use of KPIs within QMS frameworks. ISO 9001 clause 9 requires organizations to evaluate performance using appropriate data. ISO 13485 clauses 8.2.5 and 8.2.6 require monitoring and measurement of processes and products to demonstrate QMS effectiveness and product quality consistency. ICH Q10 chapter 4 highlights management review as a structured process where KPIs provide objective input for decision-making. The FDA Quality Metrics Program further stresses that effective use of quality metrics is one characteristic of robust site quality management maturity.
What Are the Benefits of Tracking Quality KPIs?
The main benefits of tracking quality KPIs are listed below.
- Improved Product Quality and Patient Safety: Quality KPIs enable monitoring of product quality and identification of trends, ensuring that products consistently meet specifications.
- Improved Decision-Making: Quality KPIs provide objective data to support informed and timely management actions.
- Early Detection of Quality Issues: Leading indicators are used to identify risks before they escalate into larger quality issues.
- Enhanced Regulatory Compliance: Quality KPIs demonstrate QMS maturity and adherence to regulatory expectations.
- Data-Driven Continuous Improvement: KPI results can be used for trend analysis, root cause investigation, and process improvement.
- Operational Efficiency Gains: Quality KPIs highlight process inefficiencies and help to reduce waste, rework, and delays.
- Better Risk Management: Quality KPIs are part of a proactive QMS, giving the ability to anticipate, mitigate, and control risks.
- Customer Satisfaction and Trust: Quality KPIs can serve as a foundation for customer satisfaction by supporting consistent product or service quality.
- Performance Transparency Across Teams: Key performance indicators promote accountability and collaboration by making results visible across the organization.
- Alignment with Strategic Quality Objectives: Quality KPIs connect day-to-day operations with broader company quality goals.
- Audit Readiness and Documentation Support: Quality KPIs monitoring, support the maintenance of organized records for inspections and audits.
How to Implement Quality KPIs?
To implement quality KPIs, the following steps are required.
- Align KPIs with Quality Objectives: Define indicators that directly support organizational quality objectives.
- Secure Leadership Commitment: Ensure management commitment for KPI tracking and review, as well as resource allocation to achieve desired outcomes.
- Identify Key Result Areas (KRAs): Focus on critical areas where measurable outcomes are essential for success.
- Apply SMART Criteria: Define KPIs that are specific, measurable, achievable, relevant, and time-bound to ensure clarity and focus.
- Balance Leading and Lagging Indicators: Combine predictive measures, such as process capability, with outcome-based metrics, such as complaint rates, to gain a full view of performance.
- Set Baseline Values and Targets: Establish current performance baselines and define clear, realistic improvement targets.
- Consult Cross-Functional Teams: Engage stakeholders from quality, manufacturing, regulatory, and supply chain to ensure KPIs reflect broad organizational priorities and drive shared accountability.
- Assign Ownership and Accountability: Designate responsible individuals or teams for monitoring and reporting results.
- Identify Reliable Data Sources: Use reliable sources to collect accurate performance data.
- Establish Data Collection Processes: Standardize the procedure for capturing and storing KPI data consistently.
- Visualize KPIs Using Dashboards: Present performance trends in an accessible format for quick interpretation.
- Monitor Performance Regularly: Track progress at defined intervals to detect trends.
- Act on the Data: Use KPI insights to implement corrective actions, preventive measures, or process improvements.
- Review and Refine KPIs Regularly: Reassess indicators to ensure ongoing relevance to evolving quality objectives.
By selecting the right KPIs, a company can successfully measure progress toward strategic quality goals. The right KPIs are those that reflect organizational priorities and drive meaningful improvement. Conversely, poorly defined or misaligned indicators can lead to wasted effort and misleading conclusions.
Applying SMART criteria is the most critical step in selecting the right KPI. For example, a SMART quality KPI is to increase RFT from 90% to 92% within one year at a pharmaceutical manufacturing site. RFT will be measured using QMS data from deviations and quality events, with progress reported monthly by the QA department. The target is achievable since the main cause of process inconsistencies, calibration drift, has already been addressed by adjusting calibration schedules to occur one month before due dates. Improving RFT is relevant to business goals, since it is tied to cost reduction, regulatory compliance, and product safety.
How Many Quality KPIs Should You Track?
Life science organizations should typically track 7 to 15 quality KPIs. There is no universal number of KPIs that a company should track, as each company must select the indicators that align with its strategic quality goals and operational priorities.
The number of KPIs that companies choose to track is influenced by the following factors.
- Regulatory and Industry Requirements: Compliance obligations define certain mandatory measures for monitoring product quality and QMS effectiveness.
- Company Size and Complexity: Larger or more complex organizations may require a broader set of KPIs.
- Quality Objectives: Strategic quality goals determine which areas of performance need monitoring.
- Available Resources: Data collection, reporting, and review capacity affect how many KPIs can be managed effectively.
- Maturity of the Quality System: More mature systems can sustain a broader set of meaningful KPIs.
Quality requirements, such as ISO 9001 and ICH Q10, emphasize measuring progress toward quality objectives and evaluating the performance and effectiveness of the QMS, rather than prescribing a fixed number of KPIs.
How Often Should You Review and Update Quality KPIs?
Quality KPIs should be reviewed and updated typically once per year, during the management review process, when performance from the previous year is evaluated against goals. More frequent reviews may be required for critical processes or during significant organizational or regulatory changes.
The review frequency is determined by the following factors.
- Regulatory Requirements: Changes in regulatory requirements may mandate updates of quality KPIs.
- Business and Quality Objectives: Shifts in strategic goals require KPI adjustments.
- Performance Triggers: A KPI consistently missing its target or experiencing a sharp trend change should trigger an immediate, ad-hoc review.
- Organizational Changes: Expansions, mergers, or new projects can trigger KPI revisions.
ICH Q10 and ISO 9001 require assessment of performance indicators during management reviews, with improvements to the QMS defined as outputs of these reviews.
Once quality KPIs have been established, the frequency of review of quality KPI data depends on the nature of the KPI. Operational KPIs (e.g., RFT, deviation rate, CAPA closure time) are typically reviewed monthly or quarterly to ensure early detection of issues. More strategic KPIs (e.g., audit performance, customer satisfaction metrics) may be reviewed less frequently (quarterly or biannually) to support long-term quality planning.
What Are the Common Mistakes to Avoid in Quality KPI Management?
The common mistakes in quality KPI management are listed below.
- Tracking Too Many KPIs: Dilutes focus and makes it difficult to prioritize and act on the most critical indicators.
- Choosing Vague or Irrelevant Metrics: Provides little meaningful insight into actual quality performance or strategic objectives.
- Ignoring Data Accuracy and Integrity: Leads to unreliable results and poor decision-making if the underlying data is flawed.
- Setting Unrealistic Targets: Creates frustration and undermines confidence in the KPI tracking and evaluation processes.
- Overlooking KPI Alignment with Quality Goals: Disconnects measurement from strategic objectives, reducing KPI impact and relevance.
- Failing to Review KPIs Regularly: Fails to drive actionable outcomes and hinders continuous improvement efforts.
- Neglecting Cross-Functional Input: Limits KPI relevance by excluding perspectives from different departments.
- Using KPIs Without Context or Baselines: Makes results difficult to interpret and trends impossible to track.
- Relying Only on Lagging Indicators: Delays improvements or corrective action by focusing solely on outcomes instead of predictive signals.
- Delaying Corrective Action Based on KPI Insights: Weakens the effectiveness of monitoring by not acting quickly on findings.
- Using KPIs as a Tool for Blame: Discourages transparency and undermines a culture of continuous improvement.
- Misinterpreting Results: Risks of drawing false conclusions without considering influencing factors or supporting data.
How Does QMS Software Support the Capture and Monitoring of Quality KPIs?
QMS software is a digital platform that centralizes quality processes, helping organizations manage core processes such as document control, training management, audit management, non-conformances handling, and other QMS activities. QMS software supports the capture and monitoring of quality KPIs by providing access to centralized and reliable data, which is used to track performance against business goals. QMS software provides structured workflows and data collection tools that allow companies to monitor, analyze, and improve performance.
A QMS platform supports quality KPI management by generating performance reports, enabling trend analysis.
The key functions of QMS software for KPI management are the following.
- Centralized Data Capture: Through a QMS platform, KPI-related data are collected from relevant modules, including deviations, CAPAs, training, and audits.
- Streamlined Reporting: QMS software provides reports and dashboards that can be used to present KPI trends and progress toward targets.
- Traceability and Audit Trails: In a centralized QMS software, all records supporting KPIs are documented, secure, and inspection-ready.
- Integration Across Processes: A QMS provides visibility of KPI data across departments, improving decision-making.
SimplerQMS is an electronic QMS designed specifically for life science companies. SimplerQMS provides a centralized platform with integrated modules for broad quality processes like document control, training management, CAPA management, supplier management, audit management, and more. SimplerQMS helps companies manage their KPIs more efficiently and effectively by using centralized data collection and report generation.
SimplerQMS supports compliance with ISO 13485:2016, ISO 9001:2015, FDA 21 CFR Parts 210, 211, and 820, EU GMP, EU MDR, EU IVDR, and ICH Q10, among others. SimplerQMS helps life science companies manage QMS processes and monitor their KPIs while maintaining compliance with regulatory requirements.
